Search Orphan Drug Designations and Approvals
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| Generic Name: | acalabrutinib | ||||||||||||||||
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| Trade Name: | CALQUENCE | ||||||||||||||||
| Date Designated: | 09/21/2015 | ||||||||||||||||
| Orphan Designation: | Treatment of mantle cell lymphoma. | ||||||||||||||||
| Orphan Designation Status: | Designated/Approved | ||||||||||||||||
| Sponsor: |
Acerta Pharma, LLC (a member of the AstraZeneca Group) 121 Oyster Point Boulevard South San Francisco, California 94080 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
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Marketing approved: |
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| 1 | Generic Name: | acalabrutinib |
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| Trade Name: | CALQUENCE | |
| Marketing Approval Date: | 10/31/2017 | |
| Approved Labeled Indication: | treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy | |
| Exclusivity End Date: | 10/31/2024 | |
| Exclusivity Protected Indication* : | treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy | |
| 2 | Generic Name: | acalabrutinib |
|---|---|---|
| Trade Name: | Calquence | |
| Marketing Approval Date: | 08/04/2022 | |
| Approved Labeled Indication: | Treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy | |
| Exclusivity End Date: | TBD | |
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